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WO2015106269A3 - Formulations d'insuline à action rapide et systèmes d'administration pharmaceutique - Google Patents

Formulations d'insuline à action rapide et systèmes d'administration pharmaceutique Download PDF

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Publication number
WO2015106269A3
WO2015106269A3 PCT/US2015/011202 US2015011202W WO2015106269A3 WO 2015106269 A3 WO2015106269 A3 WO 2015106269A3 US 2015011202 W US2015011202 W US 2015011202W WO 2015106269 A3 WO2015106269 A3 WO 2015106269A3
Authority
WO
WIPO (PCT)
Prior art keywords
insulin
delivery systems
pharmaceutical delivery
rapid action
insulin formulations
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2015/011202
Other languages
English (en)
Other versions
WO2015106269A8 (fr
WO2015106269A2 (fr
Inventor
Jeffrey I. Joseph
Richard William BERENSON
Bruce Frank
Michael A. WEISS
Thomas HATTIER
Gregory DUBÉ
Zhiqiang Chen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Thermalin Diabetes LLC
Original Assignee
Thermalin Diabetes LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to AU2015204491A priority Critical patent/AU2015204491B2/en
Application filed by Thermalin Diabetes LLC filed Critical Thermalin Diabetes LLC
Priority to JP2016563903A priority patent/JP6944780B2/ja
Priority to CA2936563A priority patent/CA2936563A1/fr
Priority to EP15735454.9A priority patent/EP3094343A4/fr
Priority to US15/110,758 priority patent/US9901622B2/en
Priority to KR1020167021822A priority patent/KR102351111B1/ko
Priority to BR112016016290A priority patent/BR112016016290A2/pt
Priority to CN201580013125.0A priority patent/CN106102763A/zh
Publication of WO2015106269A2 publication Critical patent/WO2015106269A2/fr
Publication of WO2015106269A3 publication Critical patent/WO2015106269A3/fr
Priority to IL246706A priority patent/IL246706B/en
Anticipated expiration legal-status Critical
Publication of WO2015106269A8 publication Critical patent/WO2015106269A8/fr
Priority to US15/869,350 priority patent/US10561711B2/en
Priority to US16/732,606 priority patent/US20200138911A1/en
Priority to US17/335,141 priority patent/US20210386831A1/en
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/28—Insulins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/02—Algae
    • A61K36/05—Chlorophycota or chlorophyta (green algae), e.g. Chlorella
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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    • A—HUMAN NECESSITIES
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    • A61M25/00—Catheters; Hollow probes
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    • A61M37/0092—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
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    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • A61M5/1723—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic using feedback of body parameters, e.g. blood-sugar, pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0428—Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
    • A61N1/0448—Drug reservoir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/327—Applying electric currents by contact electrodes alternating or intermittent currents for enhancing the absorption properties of tissue, e.g. by electroporation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/0253—Holding devices, e.g. on the body where the catheter is attached by straps, bands or the like secured by adhesives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M2037/0007—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/05—General characteristics of the apparatus combined with other kinds of therapy
    • A61M2205/054—General characteristics of the apparatus combined with other kinds of therapy with electrotherapy
    • A61M2205/055—General characteristics of the apparatus combined with other kinds of therapy with electrotherapy with electrophoresis
    • A—HUMAN NECESSITIES
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
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    • A61M2205/502—User interfaces, e.g. screens or keyboards
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/201—Glucose concentration

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medical Informatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Dermatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Botany (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Hematology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Anesthesiology (AREA)
  • Endocrinology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Biophysics (AREA)
  • Vascular Medicine (AREA)
  • Organic Chemistry (AREA)
  • Pulmonology (AREA)
  • Inorganic Chemistry (AREA)

Abstract

La présente invention concerne des formulations d'insuline et d'analogue d'insuline à action rapide. L'invention a également trait à des dispositifs d'administration, en particulier des ensembles de perfusion, qui permettent l'absorption rapide d'insuline et d'analogues d'insuline, ainsi que d'autres principes actifs. L'invention porte en outre sur des méthodes d'utilisation des formulations d'insuline et d'analogue d'insuline ainsi que sur les dispositifs d'administration d'insuline pour le traitement de sujets atteints de diabète sucré.
PCT/US2015/011202 2014-01-13 2015-01-13 Formulations d'insuline à action rapide et systèmes d'administration pharmaceutique Ceased WO2015106269A2 (fr)

Priority Applications (12)

Application Number Priority Date Filing Date Title
CN201580013125.0A CN106102763A (zh) 2014-01-13 2015-01-13 速效胰岛素制剂和药物递送系统
JP2016563903A JP6944780B2 (ja) 2014-01-13 2015-01-13 速効型インスリン製剤及び医薬送達システム
CA2936563A CA2936563A1 (fr) 2014-01-13 2015-01-13 Formulations d'insuline a action rapide et systemes d'administration pharmaceutique
EP15735454.9A EP3094343A4 (fr) 2014-01-13 2015-01-13 Formulations d'insuline à action rapide et systèmes d'administration pharmaceutique
US15/110,758 US9901622B2 (en) 2014-01-13 2015-01-13 Rapid action insulin formulations and pharmaceutical delivery systems
KR1020167021822A KR102351111B1 (ko) 2014-01-13 2015-01-13 초속효성 인슐린 제형 및 약제학적 전달 시스템
BR112016016290A BR112016016290A2 (pt) 2014-01-13 2015-01-13 Composições farmacêuticas de insulina de ação rápida, conjunto de infusão, sistema de conjunto de infusão e usos de análogos monoméricos ou diméricos de insulina
AU2015204491A AU2015204491B2 (en) 2014-01-13 2015-01-13 Rapid action insulin formulations and pharmaceutical delivery systems
IL246706A IL246706B (en) 2014-01-13 2016-07-11 Fast-acting insulin preparations and pharmaceutical delivery systems
US15/869,350 US10561711B2 (en) 2014-01-13 2018-01-12 Rapid action insulin formulations and pharmaceutical delivery systems
US16/732,606 US20200138911A1 (en) 2014-01-13 2020-01-02 Rapid action insulin formulations and pharmaceutical delivery systems
US17/335,141 US20210386831A1 (en) 2014-01-13 2021-06-01 Rapid action insulin formulations and pharmaceutical delivery systems

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201461926946P 2014-01-13 2014-01-13
US201461926944P 2014-01-13 2014-01-13
US61/926,946 2014-01-13
US61/926,944 2014-01-13

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US15/110,758 A-371-Of-International US9901622B2 (en) 2014-01-13 2015-01-13 Rapid action insulin formulations and pharmaceutical delivery systems
US15/869,350 Continuation US10561711B2 (en) 2014-01-13 2018-01-12 Rapid action insulin formulations and pharmaceutical delivery systems

Publications (3)

Publication Number Publication Date
WO2015106269A2 WO2015106269A2 (fr) 2015-07-16
WO2015106269A3 true WO2015106269A3 (fr) 2015-10-22
WO2015106269A8 WO2015106269A8 (fr) 2016-08-18

Family

ID=53524484

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2015/011202 Ceased WO2015106269A2 (fr) 2014-01-13 2015-01-13 Formulations d'insuline à action rapide et systèmes d'administration pharmaceutique

Country Status (10)

Country Link
US (4) US9901622B2 (fr)
EP (1) EP3094343A4 (fr)
JP (3) JP6944780B2 (fr)
KR (1) KR102351111B1 (fr)
CN (1) CN106102763A (fr)
AU (1) AU2015204491B2 (fr)
BR (1) BR112016016290A2 (fr)
CA (1) CA2936563A1 (fr)
IL (1) IL246706B (fr)
WO (1) WO2015106269A2 (fr)

Families Citing this family (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE480278T1 (de) 2005-09-12 2010-09-15 Unomedical As Einfürungssystem für ein infusionsset mit einem ersten und zweiten federeinheit
US9415159B2 (en) 2010-03-30 2016-08-16 Unomedical A/S Medical device
WO2012123274A1 (fr) 2011-03-14 2012-09-20 Unomedical A/S Système d'insertion doté d'une protection pour son transport
EP2763723B1 (fr) 2011-10-05 2016-04-13 Unomedical A/S Introducteur pour insertion simultanée de plusieurs éléments transcutanés
EP2583715A1 (fr) 2011-10-19 2013-04-24 Unomedical A/S Système de tube de perfusion et procédé de fabrication
EP3332810B1 (fr) 2012-11-13 2021-01-13 Adocia Formulation à action rapide d'insuline comprenant un composé anionique substitué
JP6944780B2 (ja) 2014-01-13 2021-10-06 サーマリン インコーポレイテッド 速効型インスリン製剤及び医薬送達システム
TW201630622A (zh) 2014-12-16 2016-09-01 美國禮來大藥廠 速效胰島素組合物
US10822386B2 (en) * 2014-12-24 2020-11-03 Case Western Reserve University Insulin analogues with enhanced stability and reduced mitogenicity
JO3749B1 (ar) 2015-08-27 2021-01-31 Lilly Co Eli تركيبات إنسولين سريعة المفعول
EP3405230A1 (fr) 2016-01-19 2018-11-28 Unomedical A/S Canule et dispositifs de perfusion
EP3541397A4 (fr) 2016-11-21 2020-11-04 Case Western Reserve University Analogue d'insuline à action rapide à stabilité améliorée
UY37629A (es) 2017-03-07 2018-10-31 Univ Case Western Reserve Análogos de insulina de cadena simple estabilizados por un cuarto puente disulfuro
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